In today’s food industry, innovation alone is no longer enough. Safety, transparency, scientific validation and regulatory compliance have become essential pillars for companies developing advanced ingredient solutions.
This is especially true for food enzymes – anyone can make claims. Very few can prove them.
Under the European regulatory framework, food enzymes are subject to a demanding scientific safety evaluation by EFSA as part of the EU authorisation process in the world. Managed by the European Food Safety Authority (EFSA), this evaluation aims to ensure that food enzymes are safe for consumers under their intended conditions of use.
For BDF Natural Ingredients, submitting our transglutaminase food enzyme dossier for EFSA safety evaluation represents a major scientific and regulatory milestone.
WHAT IS EFSA AND WHY DOES IT MATTER?
The European Food Safety Authority is one of the world’s most rigorous scientific bodies for food safety evaluation. Within the EU, any enzyme used in food applications must pass through EFSA’s evaluation process before it can be approved for use.
This process exists for one reason: evidence-based assessment of safety. EFSA provides independent risk assessment. For food enzymes, it evaluates whether the available evidence supports safety under the proposed condition of use.
For food manufacturers and ingredient buyers, working with a supplier that has submitted a scientific dossier to EFSA means working with a company willing to subject its enzyme, manufacturing process and safety data to independent scientific scrutiny at the highest European level.
A process that goes far beyond paperwork
Preparing and supporting a food enzyme dossier to EFSA is far more than an administrative exercise. It requires extensive scientific, technical and regulatory work. This processes can take years of work and requires collaboration of multiple disciplines, including:
Microbiology
Biotechnology
Toxicology
Food technology
Analytical chemistry
Regulatory affairs
Quality management
The objective is to provide EFSA with the scientific evidence required to assess the enzyme’s safety under its proposed conditions of use.
At BDF, this has meant years of coordination between our internal R&D, regulatory and quality teams, together with external scientific partners and specialized laboratories.
SCIENTIFIC DATA FOR SAFETY ASSESSMENT
The core of the EFSA evaluation is toxicology , but it is assessed alongside origin, manufacturing, composition, allergenicity, and exposure. Applicants provide the information required for EFSA to assess whether the enzyme raises safety concerns under its proposed conditions of use.
This includes studies such as:
- genotoxicity assessments
- repeated-dose toxicity studies
- allergenicity evaluations
- dietary exposure calculations
EFSA then evaluates this information using internationally recognized scientific standards and exposure models.
This level of scrutiny ensures that only enzymes meeting strict safety criteria can move forward within the European regulatory framework.
This is not a box-ticking exercise. It is rigorous science — and it takes both time and investment to do it properly.
Full transparency and traceability
Beyond toxicology, the dossier requires detailed characterisation and documentation covering the enzyme’s origin, manufacturing process, composition, specifications and proposed uses.
The production microorganism
The manufacturing process
Analytical controls
Every detail must be documented, justified and scientifically supported.
For BDF, this reflects a broader philosophy focused on quality, traceability and scientific rigor across all stages of ingredient development and production.
A milestone for innovation-driven companies
Reaching the EFSA submission stage represents much more than regulatory progress.
It reflects:
- strong scientific capabilities
- advanced quality systems
- investment in research and development
- commitment to European regulatory requirements
- long-term vision for the European market
At BDF, the submission of the transglutaminase dossier to EFSA marks a defining moment in our continued investment in biotechnology and advanced ingredient solutions for the food industry.
Building trust through regulatory excellence
The food sector is changing. Buyers are asking harder questions. Retailers and consumers are demanding greater transparency. Regulatory requirements are tightening across key markets.
In this context, regulatory excellence is no longer just a compliance issue — it is a competitive differentiator.
Submitting an enzyme dossier to EFSA demonstrates not only compliance, but also a proactive commitment to responsible innovation and consumer safety.
Behind a comprehensive food enzyme dossier can lie years of scientific work, collaboration and technical expertise — all aimed at ensuring that innovation, functionality and safety go hand in hand.
For BDF, this journey reflects a long-term commitment to developing reliable, high-quality ingredient solutions designed to meet the evolving needs of the global food industry.
Want to know more about our EFSA submission or our transglutaminase product range? Get in touch with us, we are happy to share more details.
Recommended regulatory notice
BDF Natural Ingredients has submitted a food enzyme dossier for the safety evaluation of its transglutaminase by EFSA. Submission does not constitute a favourable EFSA scientific opinion, EFSA approval or EU authorisation. (EFSA-Q-2026-00163).